Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01071070 | Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease | PHASE3 | COMPLETED | 216 | — | — | Nov 1, 2009 | Nov 1, 2010 | Jan 26, 2012 | 12 | China |
| NCT01003275 | Metabolic Effects of Paricalcitol | PHASE2 | COMPLETED | 22 | — | — | Oct 1, 2009 | Nov 1, 2011 | Apr 28, 2014 | 1 | United States |
| NCT00646932 | Paricalcitol Injection Phase II Trial | PHASE2 | COMPLETED | 25 | — | — | Nov 1, 2005 | - | Mar 31, 2008 | 10 | Japan |
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Glucose AUC during a 2-hour oral glucose tolerance test
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). |
| Group 2 | ACTIVE_COMPARATOR | Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg) |
| Paricalcitol followed by placebo | ACTIVE_COMPARATOR | Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. |
| Placebo followed by paricalcitol | ACTIVE_COMPARATOR | Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| paricalcitol | DRUG | Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details. |
| Placebo | DRUG | Two soft gels by mouth daily for 8 weeks |
Inclusion Criteria: 1. Subject is a Chinese male or female greater than or equal to 20 years old. 2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemod...